System for packaging and handling an implant and method of use

ABSTRACT

A system designed to store an implant together with the tools necessary to implant the stored implant, and a method of using the system. Such system includes an implant storage tool adapted to retain the implant within a storage container. The implant storage tool is operable to provide an implant applicator.

This application is a divisional of my application Ser. No. 09/660,371,filed Sep. 12, 2000 now U.S. Pat. No. 6,543,610.

FIELD OF THE INVENTION

The present invention relates to a system for packaging, handling andapplying implants. Additionally, this invention relates to a method forintroducing a corneal implant to the corneal surface.

BACKGROUND OF THE INVENTION

Current methods and devices used to store small, delicate, and normallytransparent implants entail free-floating the implant in a volume ofstorage fluid contained within a storage bottle or other container. Thismanner of storage is oftentimes used to preserve retinal transplants,brain tissue transplants, corneal implants, tissue biopsies and anyother delicate biological specimen. Free-floating storage, however,subjects a stored specimen or implant to fluid agitation, which canseverely and irreparably damage the integrity of the stored material. Inaddition, isolating transparent specimens from the storage fluid isdifficult to achieve.

Corneal implants are especially susceptible to the above describedproblem. Corneal implants are used to correct visual disorders such asMyopia or near-sightedness, Hyperopia or far-sightedness, Presbyopia ordifficulty in accommodating a change in focus, and Astigmatism. Tocorrect these disorders, the implant is introduced into the body of thecornea in known ways, such as after a flap is formed and an undersurface of the cornea is exposed. The implant, changes the shape of thecornea and alters its refractive power. These implants are generallymade of various types of hydrogels, but can include other polymers,tissue implants, or the like.

In the past, storing the corneal implant required free-floating theimplant in a volume of storage fluid contained within a storagecontainer. To retrieve the implant, one had to first locate the implantwithin the fluid, and then remove the implant using a filter device orsequestering tool. In the case of a corneal implant, locating theimplant is complicated by both the size and transparency of the implant.For instance, a corneal implant generally has a diameter of about 4.0 to7.0 mm and a center that is normally fabricated having a thicknessranging from 25 to 50 microns. Due this minuscule size, physicallygrasping the implant from the storage fluid using tweezers, or the like,is simply not practical.

Successful isolation of a corneal implant, or other specimen, generallyrequires the use of a sieve to separate the implant from the fluid.Isolating the implant in this manner, however, subjects the implant tomechanical forces, which could lead to a loss of the implant. If notdamaged, the transparent implant must still be located on the sievesurface and retrieved. The implant must therefore be grasped usingtweezers, forceps, or the like. Imparting such force upon the implant,however, can also damage the implant. Using force imparting tools tohold the implant is therefore not desirable. Current isolationtechniques are therefore difficult, time-consuming and create additionalsteps, which can also lead to implant contamination. Thus, it is desiredto have an implant storage and handling system, which allows the user torapidly and successfully retrieve the implant for prompt implantation.

Current devices used to deposit an implant onto the cornea surfacegenerally deposit the corneal implant onto the cornea surface in abunched or folded conformation. Aligning the implant in planar relationto the cornea surface requires the surgeon to manipulate or tease theimplant so as to remove any folds or bends in the implant.Problematically, the step of unfolding the implant on the cornea surfacecan cause serious trauma to the cornea surface. This trauma can lead tothe formation of edema, or other deleterious responses that lead torejection or displacement of the implant.

Thus, there is believed to be a demonstrated need for a unitarypackaging and handling system that provides the desired storagecapabilities, easy retrieval of the specimen from that storage, andtools that are operable to retrieve and utilize the specimen withoutcausing damage to the specimen or an implantation site. There is also anadditional need for a more effective method for implanting a cornealimplant onto a cornea surface.

SUMMARY OF THE INVENTION

The present invention relates to an implant packaging and handlingsystem which includes a storage bottle having an opening to receive avolume of implant storage fluid, and an implant holding tool designed toretain the implant in fluid communication with the implant storagefluid. A storage bottle stopper holds the implant holding tool, so thata portion of the implant holding tool is immersed within the storagefluid upon placement of the stopper into the bottle, placing the implantin fluid communication with the storage fluid. The implant holding toolincludes a retaining member detachably mounted to an implant applicatortool. Together they define an enclosure for retaining the implant in asecure, known storage position.

The implant applicator tool has an arcuate-shaped applicator surfacewith a plurality of openings. The arcuate shaped surface is contoured tocorrespond to the curvature of the cornea surface, which aids in theproper implantation of the implant to the cornea surface. In oneembodiment, the applicator surface has one or more recessed surfacesdesigned to hold and center the implant on the applicator surface. Oneor more recessed grooves are also provided to allow fluid to flowbetween the implant and the applicator surface.

The openings have numerous advantages. The openings provide continuousfluid communication between a retained implant and the implant storagefluid. Upon removal from storage, the openings enable the user to unfoldand orient the implant by gently passing fluid through the openings soas to float the implant into a desired central position on theapplicator tool surface. Once so positioned, the user is then able toaspirate the fluid/ from between the implant and the applicator tool,thereby resting the implant firmly against the applicator tool surface.The applicator tool also includes a central opening providing the userwith a reference point for centering the applicator surface, and thus,the implant onto the surface of the cornea.

The present invention also relates to a method of implanting a cornealimplant using the implant packaging and handling system. The initialstep includes surgically preparing the cornea surface for implantation.Next, the implant and implant holding tool are retrieved from thestorage bottle, and the retaining member removed so as to provide anapplicator tool together with implant. The applicator can then beattached to a handle for ease of use. The implant is then properlyaligned on the applicator tool and deposited onto the surgicallyprepared cornea surface. Finally, the cornea is restored.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the invention can be obtained from thedetailed description of exemplary embodiments set forth below, whenconsidered in conjunction with the appended drawings, in which:

FIG. 1 is a partial sectional view of the implant packaging and handlingsystem of the present invention;

FIG. 2 is a schematic representation of the implant applicator toolfastened to a retaining member, providing the implant storage tool ofthe present invention;

FIG. 3 is a schematic representation of the implant applicator tool ofthe present invention;

FIG. 4 is a schematic representation of the retaining member adapted toform an implant retaining enclosure when fastened to the implantapplicator tool of FIG. 3;

FIG. 5 is a bottom view of a stopper used to seal the storage bottle ofthe present invention, showing the implant storage tool engagement slotin an open position;

FIG. 6 is a cross-sectional view through the stopper of FIG. 5 taken online 10—10;

FIG. 7 is a partial sectional view of the bottle stopper positionedwithin the storage bottle, showing the implant storage tool engagementslot in a closed position;

FIG. 8 is a cross-section at view through the stopper and storage bottleof FIG. 7 taken on line 20—20;

FIG. 9 is a schematic illustration of the implant applicator toolsecured to a handle;

FIG. 10 is a side view of the implant applicator tool secured to ahandle, showing the curved surface of the implant applicator tool, whichcorresponds with the contour of the cornea surface;

FIG. 11 is a schematic representation of an implant applicator toolhaving a central opening for aligning the applicator tool with thevisual or pupillary axis of the eye;

FIG. 12 is a schematic representation of an implant applicator toolhaving a recessed surface defining a central opening and adjacentalignment slot;

FIG. 13 is a schematic representation of a retaining member adapted toengage with the applicator tools shown in FIGS. 9 and 12;

FIG. 13a is a schematic representation of a retaining member in aflattened form; and

FIGS. 14a, 14 b, 14 c, 14 d and 14 e are cross-sectional views of ahuman eye illustrating the method of introducing an implant to thecornea surface using the implant applicator tool of the presentinvention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

FIGS. 1 through 14 of the drawings show an implant packaging andhandling system 10 of the present invention. As illustrated in FIG. 1,the preferred system 10 includes a cylindrical storage bottle 11 forholding implant storage fluid (not indicated). The bottle 11 is sealedby a stopper 12 having an upper cap portion 14 and a plug portion 13,which is adapted to detachably couple to an implant storage tool 15. Aprotective safety seal 17 provides tamper resistance and maintains thestopper 12 in sealed relation to the bottle 11.

FIGS. 2 through 4 show a retaining member 16 and implant applicator tool19, which together define the implant storage tool 15. As illustrated,the retaining member 16 is adapted to detachably engage the implantapplicator tool 19, thereby defining an enclosure 41 operable to retainthe implant. Both the retaining member 16 and the applicator tool 19include a plurality of openings 18 and 22, respectively, which allowstorage fluid to communicate into the implant retaining enclosure 41. Asshown in FIG. 1, the implant retaining enclosure 41 is located on theend of storage tool 15 that is distal to the stopper 12 such that theenclosure 41 is immersed in implant storage fluid when the storage tool15 is inserted into the bottle 11. When the implant is stored, theenclosure 41 of storage tool 15 holds the implant in the storage fluid,while also providing a user with ready access to the implant. The usersimply removes the stopper 12, thereby removing the storage tool 15 fromthe bottle 11, and detaches the retaining member 16 from the applicator19 to access the implant.

As illustrated in FIG. 3, applicator tool 19 has a handle attachment arm20 connected through a body portion 21 to an implant applicator member45. The body portion 21 is preferably shaped to provide a broad handlingsurface. For instance, FIGS. 2 and 3 show a body portion 21 having abroad elliptical shape, which allows a user to more easily manipulatethe applicator tool 19. As shown, the implant applicator member 45includes an applicator surface 42 having a plurality of openings 22 toprovide fluid communication between the applicator surface 42 and animplant resting thereon. Openings 22 further allow the user to releasethe implant from the applicator surface 42. More particularly, the usercan impart force upon the implant by passing through the opening 22either a flow of fluid or a cantilever so as to forcibly separate theimplant from the applicator member surface 42 (as is shown in FIG. 14).

In a preferred embodiment, the applicator surface 42 has a centralopening 23 to help the user align the applicator surface 42 along thevisual or optical axis of the eye. As shown, the centrally positionedopening 23 defines a circular opening having a diameter greater than thediameter of the surrounding openings 22. In this way, the user isprovided with a central point of reference, which enables the user toalign the applicator surface 42 with the optical axis of the eye, andthus, properly position the implant.

In another embodiment, the applicator tool 19 may include an applicatoralignment notch 24 positioned integral to the surface 42 of theapplicator member 45. For instance, FIGS. 3 and 12 show the notch 24extending inwardly towards the centrally positioned alignment opening23. In this embodiment, the notch 24 is used to align the implant on thecornea surface 39, as well as release the implant from the applicatorsurface 42. Specifically, the notch 24 is dimensioned to allow acantilever, or like instrument, to pass through the notch, therebyallowing the user to impart force against an implant held on theapplicator surface 42. Specifically, the user lifts the application tool19 away from the cornea surface while simultaneously imparting downwardforce on the implant through the notch 24 so as to release the implant.One skilled in the art will understand that various notch positioningscan be incorporated into the applicator member 45 without departing fromthe scope of the present invention.

As shown in FIG. 2, the retaining member 16 has an outer surface 44defining a plurality of openings 18 that provide fluid communication toan implant retained by the enclosure 41. FIG. 4 shows a retaining member16 disengaged from the applicator tool 19 shown in FIG. 3. To secure theretaining member 16 to the applicator tool 19, the retaining member 16is provided with attachment tabs 26 a-c adapted to insert intocorresponding attachment slots 25 a-c integral to the applicator tool19. In use, the retaining member 16 is attached to the applicator tool19 by simply inserting the tabs 26 a-c into the respective correspondingslots 25 a-c, and then positioning the bottom surfaces 28 of retainingmember side walls 43 against the applicator surface 42. In a preferredembodiment, at least one side wall 43 has an overlapping flexibleportion 27 adapted to bend about the distal edge of the applicatorsurface 42, thereby securely clamping the retaining member 16 to theapplicator tool 19. To remove the retaining member 16, the user merelyunclamps the flexible portion 27 by bending it away from the applicatortool 19, and lifting the member 16 so as to disengage tabs 26 a-c fromslots 25 a-c.

As illustrated in FIGS. 9, 11, 12 and 13, an alternative attachment tab26 and attachment slot 25 can also be used with the present invention.For instance, FIG. 12 shows an applicator tool 19 having four separateattachment slots 25, while in comparison FIG. 3 shows an applicator tool19 having three separate attachment slots 25 a-c. It will be understoodby those skilled in the art that various embodiments for attachmentslots 25 and tabs 26 can be incorporated into the applicator tool 19 andretaining member 16 without deviating from the scope of the presentinvention.

As illustrated in FIGS. 5 through 8, a preferred embodiment of system 10includes a bottle stopper 12 adapted to receive and securely hold thehandle attachment arm 20 of the applicator tool 19. The stopper 12preferably includes an upper cap portion 14 and a plug portion 13dimensioned to insertably seal the bottle 11. FIG. 5 shows the stopperplug portion 13, which is not inserted into a storage bottle opening 46(shown in FIG. 8). In comparison to FIG. 5, FIG. 7 shows the plug 13inserted into the storage bottle opening 46. As illustrated by FIGS. 5and 7, plug portion 13, when removed from bottle opening 46, adopts anelliptical shape by distending in an outwardly direction along line the10—10. Likewise, inserting stopper 12 into bottle opening 46 causes theouter diameter of plug portion 13 to conform to the inner diameter ofthe inner bottle surface 34. In this way, the plug portion 13 becomesinwardly compressed along line 30—30. Referring to FIGS. 6 and 8,cross-section views are shown of stopper plug portion 13 in anout-of-bottle elliptical shape and an in-bottle compressed circularshape, respectively. The utility of this embodiment is described in moredetail below.

An engagement slot 32 is located integral to plug portion 13 in anorientation perpendicular to line 10—10. As illustrated in FIGS. 5through 8, the engagement slot 32 opens or closes in response to eitherthe removal or insertion of the plug portion 13 from the bottle opening46, respectively. Referring to FIGS. 5 and 6, the engagement slot 32 isshown in an open position. More particularly, when the user removes thestopper 12 from bottle opening 46, the plug portion 13 adopts anunrestrained elliptical shape by distending outwardly along the line10—10 for opening slot 32. In this way, the engagement arm 20 of theapplicator tool 19, which is held by the engagement the slot 32, iseasily separated from slot 32 once the stopper 12 is removed from thestorage bottle 11. By way of comparison, FIGS. 7 and 8 show theengagement slot 32 adopting a closed conformation upon insertion of thestopper 12 into the bottle opening 46. As shown in FIG. 7, insertion ofthe stopper 12 into the bottle 11 causes the outer surface 47 of theplug portion 13 to conform to the inner diameter of the bottle openingsurface 34, which imparts force in the direction of the line 30—30. Inthis way, the slot 32 is forced into a tight, closed conformation. Thus,the engagement arm 20 of the applicator tool 19 is held by a slot 32 ina secure position when the stopper 12 is inserted into the bottle 11.The stopper 12 is preferably made of silicone rubber, or otherelastomeric material.

FIGS. 9 and 10 show an applicator tool 19 attached to a handle 30. Theapplicator tool attachment arm 20 detachably mounts to the handle 30through a handle fastener 31. It will be understood by those skilled inthe art that numerous types of handles and handle fasteners areavailable that can be used with the applicator tool 19 without departingfrom the scope of the present invention.

As illustrated by FIG. 10, the implant applicator member 45 has a curvedapplicator surface 42, which corresponds to the curvature of the corneaimplant site. This curved surface allows the user to position the curvedapplicator surface 42 evenly across the cornea surface, enabling theimplant to be more evenly deposited onto the cornea surface. Referringto FIGS. 9 and 12, each applicator member 45 is shown having a recessedapplicator surface 29. As shown, the recessed surface 29 is preferablycircular, thereby allowing a substantially circular implant to becentrally positioned on the applicator member 45. In addition, thecentral opening 23 which is centered relative to the perimeter of thecircular recess 29, provides the user with a reference point foralignment of the applicator member 45 with the pupil diameter. In thisway, the implant can be properly aligned on the cornea surface.

FIG. 11 shows an applicator tool 19 having an applicator surface 42 withrecessed grooves 29 to allow fluid to flow between the applicatorsurface 42 and an implant supported on the surface 42. It should beunderstood by one skilled in the art that alternatively dimensionedrecesses and grooves can be formed in the applicator surface 42 withoutdeparting from the scope of the present invention. It is advantageous toprovide fluid flow between the surface 42 and the implant to enable theuser to more easily manipulate the implant while it is on the applicatorsurface 42. During storage, for example, the implant may come to rest invarious folded and bunched conformations. Once the retaining member 16is removed, the user can manipulate the implant into its desiredconformation by gently passing a volume of fluid through the openings 22and 23. More particularly, the implant will overlap a small volume offluid, thereby allowing the user to floatingly realign the implant onthe applicator surface 42. After the implant is aligned, the fluid canbe removed by simply touching the underside of the applicator member 45with a cotton swab, or like absorbent material.

FIGS. 12 and 13 show an alternative embodiment of an applicator tool 19and a retaining member 16, respectively. In this embodiment, theretaining member 16 includes four attachment tabs 26 that detachablyinsert into four corresponding applicator tool attachment slots 25. Asshown, the tool 19 and the retaining member 18 include fluidcommunication openings 22 and 18, respectively. It should be understoodthat various combinations of tabs, slots, alignment and openings can beincorporated into the tool 19 and the member 16 without deviating fromthe scope of the present invention.

FIGS. 14a through 14 e illustrate the steps of the claimed method ofimplanting an implant to an exposed surface of the cornea using thesystem of the present invention. The first step, shown in FIG. 14a,involves the surgical preparation of a portion of the outer surface ofthe cornea 38 of the eye to form a corneal flap 37, which remainsattached to the cornea 38 by way of a hinge 36. This surgical step iscommonly known in the art as a lamellar dissectomy, and is typicallyperformed using a keratome (not shown). In a preferred embodiment, theflap is cut deeply enough to dissect the Bowman's membrane portion ofthe cornea 38. Surgically preparing a corneal flap of 100 to 200microns, typically 160 to 180 microns, operates to eliminate tensioncaused by the Bowman's membrane. This step reduces the possibility ofimplant extrusion due to pressure generated within the cornea 38, whichmay be caused by the implant. As illustrated, it is preferable to leavethe corneal flap 37 attached by way of a hinge 36, thereby allowing theflap 37 to be replaced in the same orientation as before the cut.

After the surface 39 is prepared, the surgeon deposits the implant 40onto the surface 39 using the applicator 19. To retrieve the applicatortool 19, the surgeon first removes the protective seal 17 from aroundthe bottle opening. The implant holding tool 15 is then removed fromwithin the bottle 11 by removing the stopper 12, which holds the storagetool 15. The storage tool 15 is easily separated from the stopper 12 byholding the tool 15 about the body portion 21 and disengaging the tool15 from the now opened slot 32. Next, the tool arm 20 can be attached toa handle 30, and the retaining member 16 removed. Removing the member 16presents the implant 40 to the surgeon for implantation. The surgeon isable, therefore, to retrieve an implant 40 from a storage bottle 11without having to use, at the risk of damaging or losing the implant, agrasping tool, such as tweezers or surgical forceps.

The surgeon then properly aligns the implant 40 on the applicatorsurface 42 by preferably passing liquid through the openings 22. At thisstep, the surgeon may gently guidethe implant 40 to its proper alignmenton the surface 42 using a cannula 35, or other similar device. Theimplant 40 is positioned on the applicator surface 42 by drawing off thefluid located intermediate to the implant 40 and the applicator surface42. This can be done by placing a cotton swab, or other absorbentmaterial, against the underside of applicator member 45, which draws offthe fluid through openings 22.

As shown in FIG. 14b, the corneal flap 37 is pulled away from the corneaimplantation surface 39. The implant 40 is then positioned over thecornea implantation surface 39 by holding the applicator tool 19 in agenerally horizontal position over the surface 39 with the implant 40facing the surface 39. As shown, the applicator member 45 has an arcuateshaped applicator surface 42, which matches the curved shaped of thecornea surface 39. In this way, as illustrated in FIG. 14c, theapplicator member 45 can be evenly placed over the cornea surface 39,reducing trauma to the surface 39. Specifically, the implant 40 isevenly adhered to the surface 39, reducing the need for any manipulationof the implant 40 on the surface 39, which could traumatize the eye asis described above.

Referring to FIG. 14d, the implant 40 is deposited onto the surface 39by gently lifting the applicator tool 19 away from the surface 39. Asshown, the implant 40 remains adhered to the surface 39. The use of acannula 35 operable to pass a volume of fluid flow through opening 22,however, can be used to ensure proper deposition of the implant 40 ontosurface 39. As shown in FIG. 14e, once the implant is deposited onto thesurface 39, the corneal flap 37 is replaced.

Various embodiments of the invention have been described. Nevertheless,it will be understood that various modifications may be made withoutdeparting from the spirit and scope of the invention as disclosed andclaimed.

I claim:
 1. An implant applicator tool, comprising: (a) an applicatorfirst end adapted to detachably connect to a handle; (b) an applicatorsecond end having a surface contoured to hold an implant in asubstantially planar position; (c) at least a portion of said surfacehaving a plurality of openings therethrough; and (d) a retaining member,said retaining member adapted to detachably engage said applicatorsecond end surface so as to define an enclosure to retain an implant. 2.The tool claimed in claim 1, further including a handle for detachablyconnecting to said implant applicator tool.
 3. The tool claimed in claim1, wherein at least a portion of said applicator surface is arcuateshaped.
 4. The tool claimed in claim 1, wherein said implant applicatorhas a recessed surface adapted to hold the implant in a planar position.5. The tool claimed in claim 4, wherein said recessed surface defines acircular recess.
 6. The tool claimed in claim 5, wherein said circularrecess has a circumference at least as great as the circumference of acircular implant.
 7. The tool claimed in claim 1, wherein said retainingmember has one or more engagement tabs projecting from said retainingmember, said applicator having tab engagement slots correspondinglyaligned to receive said retaining member engagement tabs.
 8. The toolclaimed in claim 1, wherein said applicator second end includes acentrally positioned alignment opening.
 9. The tool claimed in claim 1or claim 8, wherein said applicator second end includes an applicatoralignment notch.
 10. The tool claimed in claim 9, wherein said notch isdimensioned to allow a cantilever to pass through the notch therebyallowing forces to be imparted against an implant held on applicatorsecond end recessed surface.
 11. The tool claimed in claimed 8, whereinsaid applicator second end includes an applicator alignment notch, thenotch extends inwardly towards said centrally positioned alignmentopening.
 12. An implant applicator tool, comprising: (a) an applicatorfirst end adapted to detachably connect to a handle; (b) an applicatorsecond end having a recessed surface contoured to hold an implant in asubstantially planar position, said recessed surface defining a circularrecess; and, (c) at least a portion of said surface having a pluralityof openings therethrough.
 13. The tool claimed in claim 12, furtherincluding a handle for detachably connecting to said implant applicatortool.
 14. The tool claimed in claim 12, wherein at least a portion ofsaid applicator surface is arcuate shaped.
 15. The tool claimed in claim12, wherein said circular recess has a circumference at least as greatas the circumference of a circular implant.
 16. The tool claimed inclaim 12, further including a retaining member, said retaining memberadapted to detachably engage said implant applicator so as to define anenclosure to retain an implant.
 17. The tool claimed in claim 16,wherein said retaining member has one or more engagement tabs projectingfrom said retaining member, said applicator having tab engagement slotscorrespondingly aligned to receive said retaining member engagementtabs.
 18. The tool claimed in claim 12, wherein said applicator secondend includes a centrally positioned alignment opening.
 19. The toolclaimed in claim 12 or claim 18, wherein said applicator second endincludes an applicator alignment notch.
 20. The tool claimed in claim19, wherein said notch is dimensioned to allow a cantilever to passthrough the notch thereby allowing forces to be imparted against animplant held on applicator second end recessed surface.
 21. The toolclaimed in claim 18, wherein said applicator second end includes anapplicator alignment notch, the notch extends inwardly towards saidcentrally positioned alignment opening.